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- Ensayo clínico NCT04639661
Predictors of Periodontal Outcomes Post-sanative Therapy
Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Fonthill, Ontario, Canadá, L0S1E5
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
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St. Catharines, Ontario, Canadá, L2S3A1
- Brock University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Have undergone sanative therapy (ST) in the past 5 to 10 years
- Age > 19 years
- Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day
Exclusion Criteria:
- Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
- Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Probing depth
Periodo de tiempo: At maintenance appointment (present day)
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This is a routine clinical measure of periodontal health (measured in mm)
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At maintenance appointment (present day)
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Probing depth
Periodo de tiempo: Pre-sanative therapy
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This is a routine clinical measure of periodontal health (measured in mm)
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Pre-sanative therapy
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Probing depth
Periodo de tiempo: 8-12 weeks post-sanative therapy
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This is a routine clinical measure of periodontal health (measured in mm)
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8-12 weeks post-sanative therapy
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Bleeding on probing
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Bleeding on probing
Periodo de tiempo: Pre-sanative therapy
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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Pre-sanative therapy
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Bleeding on probing
Periodo de tiempo: 8-12 weeks post-sanative therapy
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This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
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8-12 weeks post-sanative therapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tooth Loss
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Will be measured as the number of teeth lost due to periodontal disease
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Tooth Loss
Periodo de tiempo: Pre-sanative therapy
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Will be measured as the number of teeth lost due to periodontal disease
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Pre-sanative therapy
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Tooth Loss
Periodo de tiempo: 8-12 weeks post-sanative therapy
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Will be measured as the number of teeth lost due to periodontal disease
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8-12 weeks post-sanative therapy
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O'Leary Index of Plaque Control
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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The patient's plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces.
The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient's teeth containing plaque.
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At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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Índice de O'Leary de control de la placa
Periodo de tiempo: Terapia pre-sanativa
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El índice de placa del paciente = el número de superficies que contienen placa dividido por el número total de superficies disponibles.
El índice de placa mínimo sería del 0 %, lo que representa que no hay superficies dentales que contengan placa. El índice de placa máximo sería del 100 %, lo que representa todas las superficies de los dientes del paciente que contienen placa.
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Terapia pre-sanativa
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Índice de O'Leary de control de la placa
Periodo de tiempo: 8-12 semanas después de la terapia sanativa
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El índice de placa del paciente = el número de superficies que contienen placa dividido por el número total de superficies disponibles.
El índice de placa mínimo sería del 0 %, lo que representa que no hay superficies dentales que contengan placa. El índice de placa máximo sería del 100 %, lo que representa todas las superficies de los dientes del paciente que contienen placa.
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8-12 semanas después de la terapia sanativa
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body Mass Index (BMI)
Periodo de tiempo: Patients will complete this in an online questionnaire at present day (baseline).
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Patients will self-report their height and weight in an online questionnaire.
This information will be used to calculate BMI which is a known risk factor of periodontal disease.
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Patients will complete this in an online questionnaire at present day (baseline).
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Godin Leisure Time Exercise Questionnaire
Periodo de tiempo: Patients will complete this in an online questionnaire at present day (baseline).
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This questionnaire measures, at one time point, self-reported exercise habits for the past 7 days. This questionnaire includes 4 items and has been combined with the International Physical Activity Questionnaire. Name of score: Weekly leisure activity score; Minimum score: 0 units and Maximum score: 24 units or more and defined as "active". A higher score indicates a better outcome. |
Patients will complete this in an online questionnaire at present day (baseline).
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International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: Patients will complete this online questionnaire at present day (baseline).
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This questionnaire measures, at one time point, self-reported physical activity and sedentary behavior habits. It contains 27 items and has been combined with the Godin Leisure Time Exercise Questionnaire and modified version of the indices of estrogen exposure questionnaire in an online format. They will self-report their physical activity and sedentary behavior for the past 7 days. Name of score: Weekly physical activity score; Minimum score: 1 and defined as "low physical activity" and Maximumscore: 3 and defined as "high physical activity". A higher score indicates a better outcome. |
Patients will complete this online questionnaire at present day (baseline).
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Flavonoid and protein intake
Periodo de tiempo: Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
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Flavonoid and protein intake will be measured with the automated self-administered dietary intake (ASA-24) questionnaire.
This is an online food recall that patients will complete three times, reporting on their dietary intake from the last 24 hours.
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Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
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Lifetime estrogen exposure (LEE)
Periodo de tiempo: Patients will complete this online questionnaire at present day (baseline).
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The indices of estrogen exposure questionnaire will be used to determine LEE using the estimated lifetime estrogen exposure (ELEE) model.
The ELEE reflects the reproductive span, comprising a woman's time between age at menarche and age at menopause (or age at recruitment minus age at menarche for pre-menopausal women) minus 1 year for each pregnancy and duration of breastfeeding, calculated at the time at recruitment.
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Patients will complete this online questionnaire at present day (baseline).
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Dietary supplement and tea intake
Periodo de tiempo: Patients will complete this questionnaire online prior to their maintenance appointment
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Intakes of specific dietary supplements and tea will be measured using a dietary supplement and tea intake questionnaire.
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Patients will complete this questionnaire online prior to their maintenance appointment
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COVID-19 Interview questions
Periodo de tiempo: Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
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Patients will be asked interview questions about changes to their dietary intake, physical activity and oral hygiene habits resulting from the COVID-19 pandemic
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Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wendy E Ward, PhD, Brock University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20-070
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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